[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642984":3},{"organization":4,"outcomesModule":7,"designInfo":66,"detailedDescription":74,"studyPopulation":11,"armGroups":75,"interventions":97,"overallOfficials":11,"centralContacts":112,"locations":118,"responsibleParty":135,"collaborators":11,"id":139,"slug":11,"hasResults":140,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":11,"eligibilityCriteria":144,"healthyVolunteers":140,"sex":145,"minAge":146,"maxAge":147,"enrollmentInfo":148,"targetDuration":11,"studyType":151,"phases":152,"briefSummary":154,"conditions":155,"keywords":157,"overallStatus":120,"whyStopped":11,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":173},{"fullName":5,"class":6},"China-Japan Friendship Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Percentage of weight loss.",null,"Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.",[14,16,18,20,22,24,26,28,30,32,34,36,38,40,42,44,46,48,50,52,54,56,58,60,62,64],{"measure":15,"description":11,"timeFrame":12},"Weight in kilograms",{"measure":17,"description":11,"timeFrame":12},"Waist circumference in centimeters",{"measure":19,"description":11,"timeFrame":12},"Hip circumference in centimeters",{"measure":21,"description":11,"timeFrame":12},"Blood pressure",{"measure":23,"description":11,"timeFrame":12},"Serum creatinine",{"measure":25,"description":11,"timeFrame":12},"Glomerular filtration rate",{"measure":27,"description":11,"timeFrame":12},"Fasting blood glucose",{"measure":29,"description":11,"timeFrame":12},"Average blood glucose from continuous glucose monitoring",{"measure":31,"description":11,"timeFrame":12},"Postprandial 2-hour blood glucose",{"measure":33,"description":11,"timeFrame":12},"HbA1c",{"measure":35,"description":11,"timeFrame":12},"Urinary microalbumin",{"measure":37,"description":11,"timeFrame":12},"Total cholesterol",{"measure":39,"description":11,"timeFrame":12},"Low-Density Lipoprotein(LDL)",{"measure":41,"description":11,"timeFrame":12},"Triglycerides",{"measure":43,"description":11,"timeFrame":12},"Alanine Aminotransferase(ALT)",{"measure":45,"description":11,"timeFrame":12},"Aspartate Aminotransferase(AST)",{"measure":47,"description":11,"timeFrame":12},"urine microalbumin-to-creatinine ratio (ACR)",{"measure":49,"description":11,"timeFrame":12},"uric acid(UA)",{"measure":51,"description":11,"timeFrame":12},"body fat percentage(BFP)",{"measure":53,"description":11,"timeFrame":12},"Visceral fat area",{"measure":55,"description":11,"timeFrame":12},"Muscle mass in kilograms",{"measure":57,"description":11,"timeFrame":12},"Body fat percentage",{"measure":59,"description":11,"timeFrame":12},"lean body mass (LBM)",{"measure":61,"description":11,"timeFrame":12},"lean body mass percentage (LBMP)",{"measure":63,"description":11,"timeFrame":12},"Liver Stiffness Measurement(LSM)",{"measure":65,"description":11,"timeFrame":12},"Controlled Attenuation Parameter(CAP)",{"allocation":67,"interventionModel":68,"interventionModelDescription":69,"primaryPurpose":70,"observationalModel":11,"timePerspective":11,"maskingInfo":71},"NON_RANDOMIZED","PARALLEL","Non-randomized assignment: A total of 200 eligible patients were assigned to either the Semaglutide(n=50) 、Mazdutide (n=50)、Tirzepatide(n=50)、control(n=50) group.\n\n1. All participants underwent sleeve gastrectomy. Basic Treatment Measures Within 0-30 days after sleeve gastrectomy, all patients received very low-calorie enteral nutrition powder (100 kcal\u002Fday). From 30 to 90 days post-surgery, a low-energy diet (400 kcal\u002Fday) was provided. Beyond 90 days post-surgery, a calorie-restricted diet was implemented (1,500 kcal\u002Fday for men and 1,200 kcal\u002Fday for women).\n2. Exposure Factor: GLP-1RA was initiated at 1 month after surgery.\n3. Grouping 3.1Control Group: Received only basic nutritional recommendation interventions after surgery.\n\n3.2Treatment Group: Initiated Semaglutide,Mazdutide,Tirzepatide at 1 month after surgery.","TREATMENT",{"masking":72,"maskingDescription":73,"whoMasked":11},"NONE","The decision to add GLP-1RAs as adjuvant therapy after sleeve gastrectomy, including which specific drug to use, is made by the attending physicians based on each patient's clinical condition. The researchers do not intervene in the treatment assignment for any patient.","Bariatric surgery is guideline-recommended as an effective obesity treatment. Substantial evidence demonstrates its ability to significantly reduce weight, improve comorbidities like type 2 diabetes (T2DM) and dyslipidemia, and lower cardiovascular risk. However, the significant heterogeneity and complex comorbidity profiles among obese patients challenge long-term effective management with single therapeutic approaches. While currently the most effective weight-loss intervention, bariatric surgery requires attention to issues such as postoperative weight regain and metabolic deterioration.\n\nIn parallel, glucagon-like peptide-1 receptor agonists (GLP-1RA) have demonstrated significant efficacy in obesity management. Agents like Semaglutide promote weight loss and metabolic improvement through mechanisms including insulin secretion promotion, appetite suppression, delayed gastric emptying, and enhanced satiety. Tirzepatide, as the first approved GLP-1\u002FGIP dual-target agonist, demonstrates superior hypoglycemic and weight loss effects compared to Semaglutide through its synergistic interaction with GLP-1. Mazdutide, the first GLP-1\u002FGCG dual-target agonist to enter phase III clinical trials in China, promotes fatty acid oxidation and energy consumption while acting synergistically with GLP-1's appetite-suppressing effect. It can effectively reduce liver fat content while achieving weight loss.\n\nGiven the distinct advantages of both bariatric surgery and GLP-1RA therapy in weight and metabolic control, this study will combine these modalities into a comprehensive treatment strategy. We will compare the long-term safety and effectiveness of different combination regimens for weight management and metabolic improvement in Chinese patients with obesity.",[76,82,87,92],{"label":77,"type":78,"description":79,"interventionNames":80},"LSG-Semaglutide group","EXPERIMENTAL","Names for Surgery: Laparoscopic Sleeve Gastrectomy. Names for drugs: Semaglutide. Dosage:The starting dose was 0.25 mg per week and was subsequently titrated up based on individual patient response to a maximum maintenance dose of 2.4 mg per week.\n\nFrequency: Once per week. Duration: The treatment continued until the completion of the 6-month postoperative period.",[81],"Combination Product: LSG-Semaglutide group",{"label":83,"type":78,"description":84,"interventionNames":85},"LSG-Mazdutide group","Names for Surgery: Laparoscopic Sleeve Gastrectomy. Names for drugs:Mazdutide. Dosage:The starting dose was 2 mg per week and was subsequently titrated up based on individual patient response to a maximum maintenance dose of 6 mg per week.\n\nFrequency: Once per week. Duration: The treatment continued until the completion of the 6-month postoperative period.",[86],"Combination Product: LSG-Mazdutide group",{"label":88,"type":78,"description":89,"interventionNames":90},"LSG-Tirzepatide group","Names for Surgery: Laparoscopic Sleeve Gastrectomy. Names for drugs:Tirzepatide. Dosage:The starting dose was 2.5 mg per week and was subsequently titrated up based on individual patient response to a maximum maintenance dose of 10 mg per week.\n\nFrequency: Once per week. Duration: The treatment continued until the completion of the 6-month postoperative period.",[91],"Combination Product: LSG-Tirzepatide group",{"label":93,"type":6,"description":94,"interventionNames":95},"LSG group","Names for Surgery: Laparoscopic Sleeve Gastrectomy. Names for drugs: N\u002FA. Observation Group: Received only basic nutritional recommendation interventions after surgery.",[96],"Procedure: LSG group",[98,102,105,108],{"type":99,"name":77,"description":100,"armGroupLabels":101,"otherNames":11},"COMBINATION_PRODUCT","1. Basic Treatment Measures Within 0-30 days after sleeve gastrectomy, all patients received very low-calorie enteral nutrition powder (100 kcal\u002Fday). From 30 to 90 days post-surgery, a low-energy diet (400 kcal\u002Fday) was provided. Beyond 90 days post-surgery, a calorie-restricted diet was implemented (1,500 kcal\u002Fday for men and 1,200 kcal\u002Fday for women).\n2. In addition to laparoscopic sleeve gastrectomy and postoperative basic nutritional counseling,the LSG-Semaglutide group received subcutaneous semaglutide injections from 1 to 6 months postoperatively.The specific protocol was as follows:In the intervention group, semaglutide treatment was initiated at 1 month after LSG. The starting dose was 0.25 mg per week and was subsequently titrated up based on individual patient response to a maximum maintenance dose of 2.4 mg per week. The treatment continued until the completion of the 6-month postoperative period.",[77],{"type":99,"name":83,"description":103,"armGroupLabels":104,"otherNames":11},"1. Basic Treatment Measures Within 0-30 days after sleeve gastrectomy, all patients received very low-calorie enteral nutrition powder (100 kcal\u002Fday). From 30 to 90 days post-surgery, a low-energy diet (400 kcal\u002Fday) was provided. Beyond 90 days post-surgery, a calorie-restricted diet was implemented (1,500 kcal\u002Fday for men and 1,200 kcal\u002Fday for women).\n2. In addition to laparoscopic sleeve gastrectomy and postoperative basic nutritional counseling,the LSG-Mazdutide group received subcutaneous Mazdutide injections from 1 to 6 months postoperatively.The specific protocol was as follows:In the intervention group, Mazdutide treatment was initiated at 1 month after LSG. The starting dose was 2 mg per week and was subsequently titrated up based on individual patient response to a maximum maintenance dose of 6 mg per week. The treatment continued until the completion of the 6-month postoperative period.",[83],{"type":99,"name":88,"description":106,"armGroupLabels":107,"otherNames":11},"1. Basic Treatment Measures Within 0-30 days after sleeve gastrectomy, all patients received very low-calorie enteral nutrition powder (100 kcal\u002Fday). From 30 to 90 days post-surgery, a low-energy diet (400 kcal\u002Fday) was provided. Beyond 90 days post-surgery, a calorie-restricted diet was implemented (1,500 kcal\u002Fday for men and 1,200 kcal\u002Fday for women).\n2. In addition to laparoscopic sleeve gastrectomy and postoperative basic nutritional counseling,the LSG-Tirzepatide group received subcutaneous Tirzepatide injections from 1 to 6 months postoperatively.The specific protocol was as follows:In the intervention group, Tirzepatide treatment was initiated at 1 month after LSG. The starting dose was 2.5 mg per week and was subsequently titrated up based on individual patient response to a maximum maintenance dose of 10 mg per week. The treatment continued until the completion of the 6-month postoperative period.",[88],{"type":109,"name":93,"description":110,"armGroupLabels":111,"otherNames":11},"PROCEDURE","1. Basic Treatment Measures Within 0-30 days after sleeve gastrectomy, all patients received very low-calorie enteral nutrition powder (100 kcal\u002Fday). From 30 to 90 days post-surgery, a low-energy diet (400 kcal\u002Fday) was provided. Beyond 90 days post-surgery, a calorie-restricted diet was implemented (1,500 kcal\u002Fday for men and 1,200 kcal\u002Fday for women).\n2. Observation Group: Received only basic nutritional recommendation interventions after surgery.",[93],[113],{"name":114,"role":115,"phone":116,"phoneExt":11,"email":117},"Yishan Huang, Ph.D","CONTACT","+8618612256920","yuanwen0920@163.com",[119],{"facility":5,"status":120,"city":121,"state":11,"zip":11,"country":122,"countryCode":123,"cosmosGeoPoint":124,"geoPoint":129,"contacts":130},"RECRUITING","Beijing","China","CN",{"type":125,"coordinates":126},"Point",[127,128],116.39723,39.9075,{"lat":128,"lon":127},[131],{"name":132,"role":115,"phone":133,"phoneExt":11,"email":134},"Meng","+8618611457779","1689024958@qq.com",{"type":136,"investigatorFullName":137,"investigatorTitle":138,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Hua Meng","Prof.","100642984",false,"NCT07633639","GLP-1 Therapy After Bariatric Surgery in Chinese Patients With Obesity","The Efficacy and Safety of Adjuvant GLP-1 Receptor Agonist Therapy Following Metabolic Bariatric Surgery in Chinese Patients With Obesity: A Prospective, Monocentric, Stratified Randomized Controlled Trial","Inclusion Criteria:\n\n1. Patients undergoing initial laparoscopic sleeve gastrectomy (LSG).\n2. obesity:BMI ≥30 kg\u002Fm².\n3. Metabolic comorbidities: Diagnosis of metabolic syndrome or type 2 diabetes mellitus (T2DM) meeting standard criteria.\n4. Age range: 18-60 years (inclusive).\n5. Informed consent: Willing participation with documented consent.\n\nExclusion Criteria:\n\n1. Recent GLP-1RA use: Treatment with GLP-1 receptor agonists within 6 months preoperatively.\n2. Prior bariatric surgery: History of any metabolic\u002Fbariatric surgical procedure.\n3. Postoperative complications: Requiring reoperation for severe complications (e.g., hemorrhage, anastomotic leak).\n4. Non-indicated candidates: Patients not meeting standard bariatric surgery indications.\n5. Significant comorbidities:\n\n5.1Advanced hepatic\u002Frenal dysfunction (Child-Pugh C or eGFR \\\u003C30 mL\u002Fmin\u002F1.73m²). 5.2Active malignancy (except non-melanoma skin cancers). 5.3Autoimmune disorders requiring immunosuppression. 5.4Uncontrolled psychiatric conditions (e.g., active psychosis, severe depression).","ALL","18 Years","60 Years",{"count":149,"type":150},200,"ESTIMATED","INTERVENTIONAL",[153],"NA","Obese patients exhibit considerable heterogeneity and complex comorbidities, making long-term effective management challenging with monotherapy. While bariatric surgery remains the most effective weight-loss intervention, postoperative weight regain and metabolic deterioration remain significant concerns. glucagon-like peptide-1 receptor agonists (GLP-1RA) offer distinct advantages for weight loss and metabolic control, and their combination with surgery may produce synergistic effects. This study investigates the efficacy and safety of bariatric surgery combined with adjuvant GLP-1 receptor agonist therapy for Chinese patients with obesity.",[156],"Obesity",[158,159,160,161,162,163],"obesity","Glucagon-Like Peptide-1 Receptor Agonists","Metabolic Bariatric Surgery","Semaglutide","Mazdutide","Tirzepatide","2026-06-04",{"date":166,"type":167},"2026-06-08","ACTUAL",{"date":169,"type":167},"2026-05-01",{"date":171,"type":150},"2028-05-01",{"name":5,"class":6},1]